Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

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Top 20 Stem Cell Predictions for 2017

stem cell crystal ball

Stem cell crystal ball

Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.

You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.

What will 2017 bring? Below are my top 20 predictions in no particular order except starting with a few hopeful visions for the coming year.

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Stemgenex motion to dismiss aims to rebut stem cell suit claims

motion-to-dismiss-stemgenexSan Diego-based stem cell business Stemgenex is the subject of a suit over allegations about stem cell treatments. The company has now filed a motion to dismiss the case.

To me as a non-attorney, the Stemgenex motion to dismiss seems to emphasize overall vagueness of the plaintiff’s case and argues in part that there is insufficient detailed support of each claim.

From my reading of the plaintiff’s suit document, the case seems focused on alleged issues with Internet marketing claims and it provides details mainly on that level. Are all nine claims related to that? I’m not sure.

The motion to dismiss also asserts that there is a lack of detail on the specific alleged roles of each defendant as pertains to the nine claims. I’m more accustomed to reading, writing, and critiquing scientific materials (e.g. papers and grants), so court documents seem somewhat foreign to me and I don’t know what the expectations are for claims. I do feel like there are some lacunae in terms of specific details of the nine claims in the case, but is that par for the course at this stage?

Stay tuned as we all learn more about this situation and hopefully one or more experts in legal matters will weigh in on it.

Stem cell clinic lawsuits proliferate with latest against Stemgenex

StemGenexThere is a growing trend of apparently unhappy patients suing stem cell clinics, which have faced more lawsuits recently and some of these cases are proposed class action suits that could have much broader impact.

The latest case is against San Diego-based Stemgenex, a clinic that has claimed amongst other things that it can treat numerous diverse afflictions and that it has had a 100% customer satisfaction rate.

KPBS reporter David Wagner also has more on this story. Wagner also noted that Stemgenex has publicly argued for less FDA oversight of stem cells even as this case was starting to unfold. Amongst the around 600 stem cell clinics in the U.S., many of these businesses also argue for less FDA oversight.

What’s the back story on the Stemgenex case?

stemgenex-lawsuitEarlier this year there were some indications of attorneys being interested in a possible class action suit in part against a stem cell clinic in San Diego, but specifics had been lacking. Now a court document has provided new detailed information.

This case is Moorer v. StemGenex Medical Group. et at. The main named plaintiff on behalf of all the potential others in the class is Selena Moorer. A second plaintiff, Stephen Ginsberg, is mentioned later in the document as part of the “financial abuse of elders” subclass.

The defendants include the following businesses and individuals: Stemgenex, Stemgenex Medical Group, Stem Cell Research Centre, Rita Alexander, Andre Lallande D.O., Scott Sessions M.D., and DOE defendants 1-100. For the first three businesses listed as defendants, I don’t know at this time how they are interrelated versus different.

There are nine separate causes of action mentioned:

  1. “Violations of Cal. Bus. & Prof. Code § 17200 et seq
  2. Violations of Cal. Bus. & Prof. Code .§ 17500 et seq.
  3. Violations of the California Consumers Legal Remedies Cal. Civ. Code § 1750 et seq
  4. Violation of Human Experimentation Law – Cal. Health &; Safety Code § 24170, et seq
  5. Violation of the Racketeer Influenced and Corrupt Organizations Act (RICO)
  6. Fraud
  7. Negligent Misrepresentation
  8. Unjust Enrichment
  9. Financial Elder Abuse”

I’m not sure why earlier in the document it lists only 8 complaints and then later the 9 complaints listed above are mentioned. There are a lot of other potentially notable things mentioned in the document as well such as that Stemgenex charges $14,900 per treatment. If I understood the document correctly, this case has now gone from being a California suit to a federal case. I’m not sure on why and what implications that might have.

Importantly, keep in mind that we do not know if any of these allegations are factual and there is no court ruling on any of them. Stemgenex reportedly did not respond to requests from KPBS for comment. If the company comments on the case I’ll do a post on that.

What about the stem cell clinic area more broadly?

More generally, as mentioned earlier, it’s been an active year for lawsuits against stem cell clinics. The community learned last week about the second of two different stem cell lawsuits against Florida-based U.S. Stem Cell, Inc. At the end of August there were indications of a possible class action lawsuit against The Lung Institute, another stem cell clinic.

I’m not a lawyer, but I wonder if class action suits, if approved, could be combined and then end up encompassing many different clinics across the U.S. as defendants. Continue reading

2nd lawsuit alleging a U.S. stem cell clinic caused blindness

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients.U.S. Stem Cell, Inc.

What are the concerns?

Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” for vision. That case appears settled.

SEC filings by U.S. Stem Cell also disclosed another suit against them involving a different plaintiff, Patsy Bade. Note that U.S. Stem Cell Inc. used to be called Bioheart, Inc., has a subsidiary called U.S. Stem Cell Clinic LLC, and that Kristin Comella is a leader of U.S. Stem Cell.

From the SEC Filing by U.S. Stem Cell:

“On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D. During the six months ended June 30, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company.”

I’ve been wondering about the circumstances of Bade’s suit, which like the Noble case was mentioned as being in Broward County, but the Bade case didn’t appear on their county court website. As a result, I did other research as time permitted.hollywood-eye-institute

court search in the adjacent Miami-Dade County using the search term “Bioheart”, again the old name of U.S. Stem Cell, Inc., revealed that Bade had filed a lawsuit in that county against some of the same parties involved in the Noble case.

Bade has apparently settled with US Stem Cell, Inc., but as best as I could tell as a non-attorney she has not so far settled with Dr. Shareen Greenbaum and her place of business the Hollywood Eye Institute.

What did Bade claim had happened?

She alleged that a stem cell treatment she received caused her to go blind, an allegation that remains unconfirmed to my knowledge. This case raises pressing questions though. I recommend reading the amended complaint document if you want to at least try to learn more. It is publicly available on the court site and I have posted it here. U.S. Stem Cell, Inc. and its leader Kristin Comella are mentioned extensively in the amended complaint.

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